RecruitingPhase 3NCT06630585

GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes

GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes: A Prospective, Randomized, Clinical Study - The AID-JUNCT Trial


Sponsor

University of Bern

Enrollment

42 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Blood glucose management in type 1 diabetes (T1D) remains a challenge, with only \~30% of adults within the recommended consensus guidelines. Novel drugs like glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs have emerged as promising add-ons to insulin in T1D. This application has been designed to test in a prospective study whether adding a new medicine called tirzepatide (GIP/GLP-1RA) to the usual insulin therapy would make a difference for people with T1D in terms of better glucose control.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a weekly injectable medication called tirzepatide (which targets hormones GIP and GLP-1, typically used for type 2 diabetes and weight loss) to an automated insulin delivery (AID) system can improve blood sugar control in adults with type 1 diabetes. **You may be eligible if...** - You have had type 1 diabetes for at least 12 months - You are between 18 and 65 years old - You have been using an automated insulin delivery system for at least 3 months - Your HbA1c (a measure of average blood sugar) is between 6.5% and 10% - Your BMI is 23 or above **You may NOT be eligible if...** - You have had diabetic ketoacidosis or a severe hypoglycemic episode (loss of consciousness or seizure) in the past 6 months - You are pregnant or breastfeeding, or planning to become pregnant - You have severe kidney disease, severe gastroparesis, or active pancreatitis - You have a personal or family history of medullary thyroid cancer or a condition called MEN-2 - You have had significant heart problems in the past 2 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

Tirzepatide is a clear, colorless to slightly yellow solution available in cartons containing four pre-filled single-dose pens or one single-dose vial: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in a single-dose pen or vial. In this study, the investigators will start with the recommended starting dosage of tirzepatide: 2.5 mg injected subcutaneously once weekly (for four weeks). After four weeks, the dosage will be increased to 5 mg once weekly injected subcutaneously for 12 weeks.


Locations(3)

DiaCenTRE - Hirslanden Clinique des Grangettes

Chêne-Bougeries, Canton of Geneva, Switzerland

Kantonsspital Olten

Olten, Canton of Solothurn, Switzerland

Luzerner Kantonspital

Lucerne, Switzerland

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NCT06630585


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